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Corrective and preventive action (CAPA) management lets you create and maintain records of the actions that are taken to manage and resolve nonconformities or defects. By planning, tracking, and analyzing CAPA cases, you can develop efficient processes that can also help resolve similar issues. CAPA management provides a formal and controlled process for managing various types of issues that arise from manufacturing, engineering, quality, or data quality sources.
CAPA management provides the following benefits:
- It implements a case management infrastructure for identifying, correcting, and preventing future issues.
- It leads to corrective and/or preventive actions.
- It provides a tool that drives continuous improvement.
- It provides a closed-loop system that meets current Good Manufacturing Practice (cGMP) requirements and United States Food and Drug Administration (FDA) expectations. Both cGMP and FDA mandate repeatable, systematic failure investigation and root cause analysis.
CAPA management in Microsoft Dynamics 365 Supply Chain Management lets you capture issues and investigate, evaluate, and determine the root cause or causes of each issue. In this way, you can find a solution for the issue and decide how best to implement it. You can also capture and track corrective and preventive actions, and then monitor and review their effectiveness.
CAPA management provides features that automate the process to help drive continuous improvement. This approach supports the core disciplines for various quality standards, such as Six Sigma and ISO-9000. The solution is role based, supports electronic records and electronic signatures, and is fully compliant with part 11 of Title 21 of the Code of Federal Regulations (21 CFR Part 11).
CAPA management features in Supply Chain Management provide the following functionality:
- Unlimited and flexible CAPA processes – A CAPA process is a user-defined list of activities that must be performed to bring a CAPA case to a satisfactory conclusion.
- A workflow-driven process – The system automatically assigns CAPA work, based on the definition of your CAPA processes and CAPA worker groups.
- Flexible assignment of activities – Associate specific users or groups with each part of a CAPA process.
- Integration with Outlook – When work is assigned, the system can automatically send emails to notify the appropriate user that work needs their attention.
- Create CAPA cases at the point of need – The person who first recognizes an issue needs attention can create a CAPA case at the point of need in the system. The system automatically links each CAPA case to the record that it was created from (for example, the specific customer, quality order, or production order that was open when the case was created).
- Trending analysis – The CAPA workspace provides analytical tools to help you analyze CAPA trends.
The following table describes tasks that employees can perform when they work with CAPA management.
| Task | Description |
|---|---|
| Create a CAPA case | Create a new CAPA case record for a customer, vendor, product, or employee. |
| Work with a CAPA case | Add detailed information, such as activities, to a new or existing CAPA case. |
| Update the status of a CAPA case | Update the status of a CAPA case (for example, from Opened to In process). |
| Update the stage of a CAPA case | Update the stage in the process of working a CAPA case (for example, from Evaluation to Investigation). |
| Close a CAPA case | Change the status of an Opened case to Closed to indicate that the issue was resolved. |
| Rank a knowledge article | Rank a knowledge article to indicate whether it helped close a case. |